FDA 510(k)

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment

N.º K: K241722 · 2024-09-13

Fecha de decisión2024-09-13

Código de productoNHA

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K241722. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K241722.

When did Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment receive FDA 510(k) clearance?

Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment received FDA 510(k) clearance on 2024-09-13, under 510(k) number K241722.

Who is the listed applicant for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment?

The FDA product code for Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment is NHA.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Elos Medtech Pinol A/S como solicitante

K253774Elos Accurate® Denture Fixation System K251497Elos Accurate Hybrid Base K242025Elos Accurate® Hybrid Base™K231307Elos Accurate Customized Abutment K230317Elos Accurate Hybrid Base K222044Elos Accurate Customized Abutment

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.